MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; 11X80MM DISTAL STEM MODULAR CEMENTED

Catalog Number	308-01-11
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	08/27/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.Concomitant device(s): distal stem collar (cat# 308-05-26 / sn# (b)(4)), 0 mm proximal body large (cat# 308-10-05 / sn# (b)(4)), taper locking screw (cat# 308-15-01 / sn# (b)(4)), humeral adapter tray +0 (cat# 320-10-00 / sn# (b)(4)), torque defining screw kit (cat# 320-20-00 / sn# (b)(4)), 42 mm constrained humeral liner +0 (cat# 320-42-10 / sn# (b)(4)), 42 mm expanded geosphere +4 mm (cat# 320-02-42 / sn# (b)(4)), geosphere locking screw (cat# 320-15-05 / sn# (b)(4)), sup/post augment glenoid plate right (cat# 320-15-08 / sn# (b)(4)), compression screw 22 mm (cat# 320-20-22 / sn# (b)(4)), compression screw 22 mm (cat# 320-20-22 / sn# (b)(4)), compression screw 26 mm (cat# 320-20-26 / sn# (b)(4)), compression screw 26 mm (cat# 320-20-26 / sn# (b)(4)) , compression screw 30 mm (cat# 320-20-30 / sn# (b)(4)) , cement restrictor (cat# tpa-18 / sn# (b)(4)).
Event or Problem Description
As reported, approximately 9 years and 3 months post right shoulder implant, the patient had an acute event where the glenoid component and geosphere came away from the bone.Many attempts at rescheduling a revision were made and, on this day, she came in for a revision arthroplasty.The surgeon planned on putting our largest humeral head onto her hrp humeral side, but during surgery her glenoid bone was so small and other major structures (coracoid/acromium) were virtually gone.Surgeon was concerned the big ball hemi would not be contained without this ceiling so opted to remove the humeral side hrp along with everything that was loose from the glenoid, leave patient without any implants and a resection arthroplasty for pain relief purposes.Patient left the operating room in stable condition.There was no delay to the surgery.There was no reported patient injury.
Additional Manufacturer Narrative
The revision reported was likely the result of the patient¿s poor bone quality which allowed for the glenoid components to loosen.Device manufacture date: 21-feb-2017.

• Brand Name: EQUINOXE
• Common Device Name: 11X80MM DISTAL STEM MODULAR CEMENTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 9069464
• Report Number: 1038671-2019-00450
• Device Sequence Number: 2377416
• Product Code: KWT
• UDI-Device Identifier: 10885862267917
• UDI-Public: 10885862267917
• Combination Product (Y/N): N
• PMA/510(K) Number: K143659
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 308-01-11
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/27/2019
• Supplement Date Received by Manufacturer: 11/12/2019
• Initial Report FDA Received Date: 09/16/2019
• Supplement Report FDA Received Date: 11/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention